Back to resultsEfficacy of Manuel Therapy and BETY in Patients With Temporomandibular Dysfunction Related Headache
Primary Purpose
Temporomandibular Disorders, Headache
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Patient education and preventive exercise
Patient education, preventive exercise combined with Manual Therapy protocol
Patient education, preventive exercise combined with BETY approach
Sponsored by
About this trial
This is an interventional treatment trial for Temporomandibular Disorders focused on measuring Temporomandibular Disorders, Headache, Quality of Life, Pain
Eligibility Criteria
Inclusion Criteria: Ages between 18 and 60 years old Getting a diagnosis of TMD-related headache Not having received FTR and manual therapy in the last 3 months Having pain ≥ 50 or more according to the headache impact test (HIT 6) Patients who have not received medical treatment in the last 3 months and will not receive medical treatment during the treatment Patients who describe pain in the jaw, face, temporal region or ear for at least 6 months and who have pain in the chewing muscles with palpation Exclusion Criteria: Ages under 18 and over 60 years old Patients with disc displacement and/or attachment degeneration Patients with dental infection Patients who have undergone facial and ear surgery in the last six months Patients undergoing orthodontic treatment Patients using regular analgesics or anti-inflammatory drugs Patients with a history of trauma (whiplash injury, condylar trauma, fracture), Patients who have undergone any surgery related to the cervical and/or TMJ Patients with facial paralysis Patients with missing teeth in the upper jaw Patients with cognitive deficits Participation rate lower than 80% of the program schedule
Sites / Locations
- Abdulkadir Konukoğlu Sağlıklı Hayat MerkeziRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Home Exercise: Patient Education and Preventive Exercise
Manual Therapy Combined with Home Exercise
Cognitive Exercise Therapy Approach Combined with Home Exercise
Arm Description
Group 1: The home Exercise Program includes an educational training program about parafunctional activities and correction exercises for patients having TMD-related headaches. The program includes tongue resting position, diaphragmatic breathing, head posture correction exercises, stretching and strengthening exercises for shoulder and back muscles, and active cervical and thoracic mobilization.
Group 2: MT group includes in addition to the home exercise program, deep friction massage, myofascial release techniques and stretching techniques to masticatory and neck muscles, temporomandibular joint and cervical mobilization will be applied.
Group 3: Cognitive Exercise Therapy Approach (CETA) includes cognitive exercise therapy and the home exercise program. The Cognitive Exercise Therapy approach is an innovative exercise approach that aims to change the patient's cognition about the disease through exercise and is suitable for the biopsychosocial model. CETA is an exercise approach aimed at changing the patient's cognitive perception of the disease through exercise, placing the responsibility of disease management on the patient. The approach will be explained in the first session, and patients will be taught proper posture for the neck, shoulders, thoracic, and lumbopelvic region, as well as correct breathing control. Each 1-hour session will include a warm-up, exercise period, and cool-down.
Outcomes
Primary Outcome Measures
Change from baseline in Pain at 8 weeks and 5 months
A visual Analog Scale will be used where patients will be asked to rate their pain on a scale from 0 to 10 with 0 indicating no pain and 10 the maximum worst pain, at the baseline and the end of 8 weeks of intervention and at the end of 5 months from baseline.
Change from baseline in McGill Pain Questionnaire (SF-MPQ) at 8 weeks and 5 months
A short form of the McGill Pain Questionnaire (SF-MPQ) will be used. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total descriptors.
Change from baseline in pain threshold at 8 weeks and 5 months
A digital pressure pain threshold algometer measuring device will be used to narrow trigger point sensitivity (Wagner Instruments, Greenwich, USA). Pain measurements of pressure to the masseter, temporal, SCM, upper trapezius, suboccipital, and levator scapula muscles will be recorded.
Change from baseline in the Headache Impact Test (HIT-6) at 8 weeks and 5 months
The HIT-6 consists of six items: pain, social functioning, role functioning, vitality, cognitive functioning, and psychological distress. The patient answers each of the six related questions using one of the following five responses: "never", "rarely", "sometimes", "very often", or "always". These responses are summed to produce a total HIT-6 score that ranges from 36 to 78, where a higher score indicates a greater impact of headache on the daily life of the respondent. Scores can be interpreted using four groupings that indicate the severity of headache impact on the patient's life.
Change from baseline head posture analysis at 8 weeks and 5 months
Head posture will be measured in degrees with the goniometer as the angle between the horizontal plane and the seventh cervical vertebra and the ear line.
Change from baseline in the evaluation of Temporomandibular Joint (TMJ) and Cervical Region Range of Motion (ROM) at 8 weeks and 5 months
TMJ ROM: A linear ruler will be used for maximal mouth opening, right and left lateralization, and protrusion values by looking at active and passive.
Cervical ROM: In order to measure its patency, the cervical region flexion, extension, right-left lateral flexion, and right-left rotation degrees will be measured and recorded with a goniometer.
Change from baseline in the viscoelastic properties at 8 weeks and 5 months
A digital MyotonPro (Myoton AS, Estonia) instrument measuring device will be used to evaluate the viscoelastic properties of the facial and neck muscles.
Change from baseline in jaw function limitation at 8 weeks and 5 months
Jaw function limitation will be measured by the Jaw Functional Limitation Scale-20 (JFLS-20) where the patients will be asked from 1 to 10 points per item (higher scores indicate worse jaw function). The JFLS-20 has 3 subscales: Mastication (6 items), Vertical Jaw Mobility (4 items), and Emotional and Verbal Expression (10 items).
Change from baseline in the neck disability index at 8 weeks and 5 months
The neck disability index (NDI) has become a standard tool for measuring self-assessed disability due to neck pain. Each of the 10 items receives a score from 0 to 5. The maximum score is 50.Scoring intervals for interpretation; 0 to 4 = no disability, 5 to 14 = mild, 15 to 24 = moderate, 25 to 34 = severe, Above 34 = complete
Change from baseline in the Pittsburgh sleep quality index at 8 weeks and 5 months
The Pittsburgh Sleep Quality Index (PUKI) will be used to assess sleep quality. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Change from baseline in Fatigue severity at 8 weeks and 5 months
The fatigue severity scale has nine items. For each question, the patient is asked to choose a number from 1 to 7 that indicates how much the patient agrees with each statement, where 1 indicates strong disagreement and 7 indicates strong agreement. A score of 4 or higher generally indicates severe fatigue.
Change from baseline in anxiety and depression at 8 weeks and 5 months
Hospital Anxiety and Depression scale consists of 14 questions in total. The minimum score for the anxiety and depression subscales is 0, and the maximum score is 21. An increase in the score on the scale means that the severity of anxiety and depression increases. The cut-off points were determined as 10 for the anxiety subscale and 7 for the depression subscale.
Change from baseline in Quality of Life-Oral health impact profile-14 at 8 weeks and 5 months
The quality of life will be evaluated with Quality of Life-Oral health impact profile-14 (OHIP-14) questionnaire. The index provides a comprehensive measure of self-reported dysfunction, discomfort, and disability resulting from oral conditions whose dimensions are based on Locker's conceptual model of oral health. Responses are rated on a 5-point Likert scale: 0 = never; 1 = hardly ever; 2 = occasionally; 3 = quite often; 4 = very often/every day. OHIP-14 scores can range from 0 to 56 and are calculated by adding the rank values for 14 items. Area scores can range from 0 to 8. Higher OHIP-14 scores indicate worse, lower scores indicate better OHRQol.
Change from baseline in Cognitive Exercise Therapy Approach Questionnaire at 8 weeks and 5 months
It is a measurement tool developed in accordance with the biopsychosocial model and evaluating the biopsychosocial status of patients with rheumatic disease. This scale consists of 30 items and consists of questions assessing cognitions related to functionality, mood, fatigue, sleep, pain, sociability and sexuality. The BETY Scale is a total likert-type scale consisting of 30 items. Each item is scored between 0 and 4, and a high score is associated with poor biopsychosocial status. Responses are rated on a 5-point Likert scale; 4: Always, 3: Often, 2: Sometimes, 1: Rarely, 0: No, never
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05927545
Brief Title
Efficacy of Manuel Therapy and BETY in Patients With Temporomandibular Dysfunction Related Headache
Official Title
The Efficacy of Manual Therapy and BETY on Headache and Quality of Life in Patients With Temporomandibular Dysfunction Related Headache
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
June 25, 2024 (Anticipated)
Study Completion Date
December 25, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasan Kalyoncu University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of the study is to investigate the effects of Manual Therapy and the Cognitive Exercise Therapy Approach treatment in patients with TMD-related headaches.
Detailed Description
60 subjects with TMD-related headaches, according to ICHD-3, will be included in the study after the voluntary consent form will be filled out. Subjects will randomly be divided into 3 groups according to the order.
Group 1: Patient education and exercise group: The patients in this group will be taught an exercise program after general education. Education training program about parafunctional activities of TMD and active exercises for masticatory and neck muscles. Patients will be asked to complete and follow-up home exercises for 30-45 minutes once a day, 5 days a week for 8 weeks. The continuity of the exercises will be ensured by sending reminder messages to this group of patients about doing their exercises once a week by the physiotherapist.
Group 2; Manuel Therapy group: This group will receive the same patient education and exercises additionally manual therapy program which is planned to last 45 minutes will be applied twice a week, for 8 weeks.
Group 3; BETY group: This group will receive the same patient education and exercises in addition BETY approach, which is the Cognitive Exercise Therapy Approach treatment, will be applied in 2 sessions a week for 45 minutes and a total of 8 weeks of treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorders, Headache
Keywords
Temporomandibular Disorders, Headache, Quality of Life, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Home Exercise: Patient Education and Preventive Exercise
Arm Type
Active Comparator
Arm Description
Group 1: The home Exercise Program includes an educational training program about parafunctional activities and correction exercises for patients having TMD-related headaches. The program includes tongue resting position, diaphragmatic breathing, head posture correction exercises, stretching and strengthening exercises for shoulder and back muscles, and active cervical and thoracic mobilization.
Arm Title
Manual Therapy Combined with Home Exercise
Arm Type
Active Comparator
Arm Description
Group 2: MT group includes in addition to the home exercise program, deep friction massage, myofascial release techniques and stretching techniques to masticatory and neck muscles, temporomandibular joint and cervical mobilization will be applied.
Arm Title
Cognitive Exercise Therapy Approach Combined with Home Exercise
Arm Type
Active Comparator
Arm Description
Group 3: Cognitive Exercise Therapy Approach (CETA) includes cognitive exercise therapy and the home exercise program. The Cognitive Exercise Therapy approach is an innovative exercise approach that aims to change the patient's cognition about the disease through exercise and is suitable for the biopsychosocial model. CETA is an exercise approach aimed at changing the patient's cognitive perception of the disease through exercise, placing the responsibility of disease management on the patient. The approach will be explained in the first session, and patients will be taught proper posture for the neck, shoulders, thoracic, and lumbopelvic region, as well as correct breathing control. Each 1-hour session will include a warm-up, exercise period, and cool-down.
Intervention Type
Procedure
Intervention Name(s)
Patient education and preventive exercise
Intervention Description
Educational training program and prevention exercises about temporomandibular dysfunction in patients with temporomandibular dysfunction-associated headaches.
Intervention Type
Procedure
Intervention Name(s)
Patient education, preventive exercise combined with Manual Therapy protocol
Intervention Description
Manual therapy program combined with the educational training program and prevention exercise about temporomandibular dysfunction in patients with temporomandibular dysfunction-associated headaches.
Intervention Type
Procedure
Intervention Name(s)
Patient education, preventive exercise combined with BETY approach
Intervention Description
BETY therapy program combined with the educational training program and prevention exercise about temporomandibular dysfunction in patients with temporomandibular dysfunction-associated headaches.
Primary Outcome Measure Information:
Title
Change from baseline in Pain at 8 weeks and 5 months
Description
A visual Analog Scale will be used where patients will be asked to rate their pain on a scale from 0 to 10 with 0 indicating no pain and 10 the maximum worst pain, at the baseline and the end of 8 weeks of intervention and at the end of 5 months from baseline.
Time Frame
Baseline, 8 weeks, 5 months
Title
Change from baseline in McGill Pain Questionnaire (SF-MPQ) at 8 weeks and 5 months
Description
A short form of the McGill Pain Questionnaire (SF-MPQ) will be used. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total descriptors.
Time Frame
Baseline, 8 weeks, 5 months
Title
Change from baseline in pain threshold at 8 weeks and 5 months
Description
A digital pressure pain threshold algometer measuring device will be used to narrow trigger point sensitivity (Wagner Instruments, Greenwich, USA). Pain measurements of pressure to the masseter, temporal, SCM, upper trapezius, suboccipital, and levator scapula muscles will be recorded.
Time Frame
Baseline, 8 weeks, 5 months
Title
Change from baseline in the Headache Impact Test (HIT-6) at 8 weeks and 5 months
Description
The HIT-6 consists of six items: pain, social functioning, role functioning, vitality, cognitive functioning, and psychological distress. The patient answers each of the six related questions using one of the following five responses: "never", "rarely", "sometimes", "very often", or "always". These responses are summed to produce a total HIT-6 score that ranges from 36 to 78, where a higher score indicates a greater impact of headache on the daily life of the respondent. Scores can be interpreted using four groupings that indicate the severity of headache impact on the patient's life.
Time Frame
Baseline, 8 weeks, 5 months
Title
Change from baseline head posture analysis at 8 weeks and 5 months
Description
Head posture will be measured in degrees with the goniometer as the angle between the horizontal plane and the seventh cervical vertebra and the ear line.
Time Frame
Baseline, 8 weeks, 5 months
Title
Change from baseline in the evaluation of Temporomandibular Joint (TMJ) and Cervical Region Range of Motion (ROM) at 8 weeks and 5 months
Description
TMJ ROM: A linear ruler will be used for maximal mouth opening, right and left lateralization, and protrusion values by looking at active and passive.
Cervical ROM: In order to measure its patency, the cervical region flexion, extension, right-left lateral flexion, and right-left rotation degrees will be measured and recorded with a goniometer.
Time Frame
Baseline, 8 weeks, 5 months
Title
Change from baseline in the viscoelastic properties at 8 weeks and 5 months
Description
A digital MyotonPro (Myoton AS, Estonia) instrument measuring device will be used to evaluate the viscoelastic properties of the facial and neck muscles.
Time Frame
Baseline, 8 weeks, 5 months
Title
Change from baseline in jaw function limitation at 8 weeks and 5 months
Description
Jaw function limitation will be measured by the Jaw Functional Limitation Scale-20 (JFLS-20) where the patients will be asked from 1 to 10 points per item (higher scores indicate worse jaw function). The JFLS-20 has 3 subscales: Mastication (6 items), Vertical Jaw Mobility (4 items), and Emotional and Verbal Expression (10 items).
Time Frame
Baseline, 8 weeks, 5 months
Title
Change from baseline in the neck disability index at 8 weeks and 5 months
Description
The neck disability index (NDI) has become a standard tool for measuring self-assessed disability due to neck pain. Each of the 10 items receives a score from 0 to 5. The maximum score is 50.Scoring intervals for interpretation; 0 to 4 = no disability, 5 to 14 = mild, 15 to 24 = moderate, 25 to 34 = severe, Above 34 = complete
Time Frame
Baseline, 8 weeks, 5 months
Title
Change from baseline in the Pittsburgh sleep quality index at 8 weeks and 5 months
Description
The Pittsburgh Sleep Quality Index (PUKI) will be used to assess sleep quality. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Time Frame
Baseline, 8 weeks, 5 months
Title
Change from baseline in Fatigue severity at 8 weeks and 5 months
Description
The fatigue severity scale has nine items. For each question, the patient is asked to choose a number from 1 to 7 that indicates how much the patient agrees with each statement, where 1 indicates strong disagreement and 7 indicates strong agreement. A score of 4 or higher generally indicates severe fatigue.
Time Frame
Baseline, 8 weeks, 5 months
Title
Change from baseline in anxiety and depression at 8 weeks and 5 months
Description
Hospital Anxiety and Depression scale consists of 14 questions in total. The minimum score for the anxiety and depression subscales is 0, and the maximum score is 21. An increase in the score on the scale means that the severity of anxiety and depression increases. The cut-off points were determined as 10 for the anxiety subscale and 7 for the depression subscale.
Time Frame
Baseline, 8 weeks, 5 months
Title
Change from baseline in Quality of Life-Oral health impact profile-14 at 8 weeks and 5 months
Description
The quality of life will be evaluated with Quality of Life-Oral health impact profile-14 (OHIP-14) questionnaire. The index provides a comprehensive measure of self-reported dysfunction, discomfort, and disability resulting from oral conditions whose dimensions are based on Locker's conceptual model of oral health. Responses are rated on a 5-point Likert scale: 0 = never; 1 = hardly ever; 2 = occasionally; 3 = quite often; 4 = very often/every day. OHIP-14 scores can range from 0 to 56 and are calculated by adding the rank values for 14 items. Area scores can range from 0 to 8. Higher OHIP-14 scores indicate worse, lower scores indicate better OHRQol.
Time Frame
Baseline, 8 weeks, 5 months
Title
Change from baseline in Cognitive Exercise Therapy Approach Questionnaire at 8 weeks and 5 months
Description
It is a measurement tool developed in accordance with the biopsychosocial model and evaluating the biopsychosocial status of patients with rheumatic disease. This scale consists of 30 items and consists of questions assessing cognitions related to functionality, mood, fatigue, sleep, pain, sociability and sexuality. The BETY Scale is a total likert-type scale consisting of 30 items. Each item is scored between 0 and 4, and a high score is associated with poor biopsychosocial status. Responses are rated on a 5-point Likert scale; 4: Always, 3: Often, 2: Sometimes, 1: Rarely, 0: No, never
Time Frame
Baseline, 8 weeks, 5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ages between 18 and 60 years old
Getting a diagnosis of TMD-related headache
Not having received FTR and manual therapy in the last 3 months
Having pain ≥ 50 or more according to the headache impact test (HIT 6)
Patients who have not received medical treatment in the last 3 months and will not receive medical treatment during the treatment
Patients who describe pain in the jaw, face, temporal region or ear for at least 6 months and who have pain in the chewing muscles with palpation
Exclusion Criteria:
Ages under 18 and over 60 years old
Patients with disc displacement and/or attachment degeneration
Patients with dental infection
Patients who have undergone facial and ear surgery in the last six months
Patients undergoing orthodontic treatment
Patients using regular analgesics or anti-inflammatory drugs
Patients with a history of trauma (whiplash injury, condylar trauma, fracture),
Patients who have undergone any surgery related to the cervical and/or TMJ
Patients with facial paralysis
Patients with missing teeth in the upper jaw
Patients with cognitive deficits
Participation rate lower than 80% of the program schedule
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aysenur TUNCER, PT, PhD
Phone
+90-342 2118080
Email
aysenur.tuncer@hku.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Feride ATAY, PT, MSc
Phone
+90 5426066002
Email
feride_atay@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aysenur TUNCER, PhD
Organizational Affiliation
Hasan Kalyoncu University
Official's Role
Study Director
Facility Information:
Facility Name
Abdulkadir Konukoğlu Sağlıklı Hayat Merkezi
City
Gaziantep
ZIP/Postal Code
27560
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feride ATAY, PT, MSc
Phone
+90 5426066002
Email
feride_atay@hotmail.com
First Name & Middle Initial & Last Name & Degree
Aysenur TUNCER, PT, PhD
Phone
+90-342 2118080
Email
aysenur.tuncer@hku.edu.tr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Manuel Therapy and BETY in Patients With Temporomandibular Dysfunction Related Headache
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